1. Field of the Invention
The invention relates to an accessory for a body orifice, by which we mean an external opening in an internal passage of a living body. The accessory takes the form of an abutment for use in providing a closure for such an opening. The invention is applicable by way of example in a stoma closure such as may be used in sealing an artificial anus, and will be further described for convenience in that context although it is evidently applicable more generally to orifices whether artificial or not.
The invention accordingly relates more particularly to a device for sealing an artificial anus by means of a flexible closure plug introduced into the lumen of the intestine of the artificial anus, the device comprising an abutment portion for laying on the outside of the body, generally the abdominal wall of the user. 2. Description of the Prior Art
Devices of this kind have previously been proposed, in which the sealing apparatus has a partially inflexible external portion and a flexible cushion-like, internal portion (U.S. Pat. No. 2,564,399 and U.S. Pat. No. 3,447,533). The inflexible portion of the closure plug is intended to extend through the muscular body wall of the user, an abutment portion resting against the outside of the user's body, whilst the flexible portion of the closure plug is intended to be expanded radially behind the body wall in the lumen of the intestine for the purpose of anchoring the device in the artificial anus.
For the purpose of expanding the flexible closure plug section radially, it has been proposed to contract the closure plug axially by means of a chain, string or springs (U.S. Pat. No. 3,447,533). It has also been proposed to make the flexible portion of the closure plug in the manner of an inflatable flexible bladder of rubber or the like, for inflation from the outside by means of a rubber ball (U.S. Pat. No. 2,564,399). In these devices a relatively complicated technical construction is necessary, for achieving the radial expansion of the inserted closure plug. Consequently the device is technically complicated, particularly prone to contamination and difficulty is experienced both in preventing its involuntary release and, in a mechanical sense, in its use by the elderly, who are the principal users of an artificial anus in cases of cancer of the large intestine. Moreover adequate sealing of the artificial anus cannot be accomplished with these previously proposed devices, particularly against intestinal gases and liquids which temporarily distort the flexible, radially expandable closure plug portion and are pushed out past the partially inflexible closure plug portion. The appliances constructed in accordance with the two U.S. Patent Specifications are indisposable and consequently the cleansing required is nauseating.
In practice therefore tightly fitting closures or plastics bags attachable by adhesion continue to be used. These two arrangements however have considerable disadvantages. The known closures have to be pressed on by means of a girdle under fairly substantial pressure in order to seal the artificial anus. Apart from the fact that the wearing of such closures is consequently unpleasant, the use of such closures tends to distort the intestinal tissues and to cause haemorrhages and inflammation. During movements of the body, the closure may moreover become displaced from the artificial anus, so that the latter is frequently exposed. The adhesively attachable plastics bags, on the other hand, are intended and suitable only for collecting, but not for holding back excreta and intestinal gases. Since a person equipped with an artificial anus lacks the facility to hold back excreta and intestinal gases voluntarily and the discharge of excrete and intestinal gases into the plastics bag causes considerable acoustically apprehensible noise and a characteristic smell during bowel movement the user is considerably handicapped socially even when such plastics bags are used properly. The adhesively attached bags moreover have the disadvantage that the weight of the more or less filled plastics bag causes discomfort and may result in the bag becoming involuntarily detached from the user's skin, particularly in summer when the skin perspires. Here also the wearing of a girdle is recommended.
In relation to the foregoing, the invention has the primary object of substantially improving devices for sealing an artificial anus or similar opening by means of a closure plug and abutment portion, in such a way that optimum conditions of cleanliness and simple operation together with comfortable application and reliable sealing are ensured.
It is another object of the invention to provide an abutment portion for such a device, offering distinctive advantages in use, such as facility for changing the closure plug without having to detach the abutment from the body of the wearer.
In British Pat. No. 31230/74 there is described and claimed a device for sealing an artificial anus, said device comprising an elongate, flexible, disposable closure plug made of absorbent material and which is adapted to be introduced into the lumen of the artificial anus, an abutment portion which is adapted to be placed on the outside of the body adjacent the artificial anus, generally on the abdominal wall of the user, said abutment portion being in the form of a disc-shaped flexible support portion and having on the side that is to face the body an annular region of adhesive material compatible with the human skin and adapted to hold the device in place on the user's body while sealing against escape of fluid from the anus, and a connection member for retaining said closure plug with said flexible support portion, said connection member being secured to, and projecting from, said side of said support portion. The connection member described in U.S. Pat. No. 1,485,825 is a helical pin having a head large enough to prevent it being dragged through the abutment portion. As the device is constructed, the closure plug is pushed or twisted onto the pin and thereby locked in place.